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Recorded Webinar

Effective Management Reviews for FDA and Management

timelapse 60 Min with 15 Min QnA of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

Effective Management Reviews will not only meet the regulatory requirement but also serve as valuable tool for senior management too.

Those in the medical device industry are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820. The specific regulation is Part 820.20 (c)

In this webinar, we will discuss all the essential elements for effective management review. We will discuss key requirements for the procedure, and how to schedule management reviews. We will also discuss how to measure the effectiveness of your management review program

Key Areas Covered During the Webinar:

  • What is the regulation?
  • What does FDA expect?
  • What are the key elements of a Management Review procedure?
  • What are the key elements of a Management Review procedure?
  • What data should be reviewed?
  • How often should the review occur
  • Who should attend the review.
  • How to format and report Quality Indicators
  • How do you measure the effectives of the review?


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